Search Results

The COMPLETE CONTROL System Gen2 is to be used exclusively for external prosthetic fittings of the upper limbs.

The COMPLETE CONTROL System Gen2 is an advanced control solution designed to provide the functionality of a powered myoelectric prosthesis for upper extremity amputees. The COMPLETE CONTROL System Gen2 employs pattern recognition technology to non-invasively acquire user-specific muscle signals for the control of industry-standard upper extremity prostheses. Patients can achieve control of their devices, eliminate control switching, and benefit from quick and powerful recalibration. The COMPLETE CONTROL System Gen2 simplifies electrode placement and allows a prosthetist to spend less time adjusting system settings and configurations.

The COMPLETE CONTROL System Gen2 is designed to work seamlessly with most major manufacturers' devices as an easy plug-and-play add-on and does not require an additional battery.

The COMPLETE CONTROL System Gen2 is an embedded system that is used in conjunction with an upper-limb prosthetic device. The system has been validated for a specific set of prosthetic elbow, wrist and hand components which are listed in the user manual.

The COMPLETE CONTROL System Gen2 contains the following components:

• COMPLETE CONTROLLER main processor
• Device Interface Cable (clinician-specified termination type)
• EMG Interface Cable (clinician-specified termination type)
• COMPLETE CALIBRATE Button (part of COMPLETE CONTROLLER)
• Fabrication aid for the COMPLETE CONTROLLER
• Socket cut-out template for the COMPLETE CALIBRATE Button
• COMPELTE CONTROLROOM Application
• COMPLETE COMMUNICATOR Dongle

The acceptance criteria and study proving the device meets these criteria are detailed below. It is important to note that this document is a 510(k) summary for a medical device (COMPLETE CONTROL System Gen2), which aims to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device's efficacy through extensive clinical trials as would be required for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in terms of patient data or typical sample sizes seen in clinical trials. The performance evaluation primarily focuses on non-clinical bench testing and adherence to international electrical safety and EMC standards. Therefore, an explicit sample size for human subjects or their data provenance (country of origin, retrospective/prospective) is not applicable in the context of this 510(k) summary, as human clinical testing was not required for this submission. The tests performed were on the device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the evaluation primarily involved non-clinical bench testing and adherence to standards, not the establishment of ground truth for diagnostic or prognostic interpretations by clinical experts.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above. The testing was objective measurement against predefined technical specifications and international standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not conducted and is not mentioned in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to a predicate device through technical and performance comparisons, not on measuring human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

The testing described is primarily standalone in nature, as it evaluates the device's adherence to electrical safety standards, EMC, and its internal functionality (cabling, power, Bluetooth, inputs, outputs, calibration, pattern recognition, file save). The "algorithm only" aspect is embedded within the "Calibration and Pattern Recognition Test," which confirms the device's ability to perform its core function. However, this is integrated into the device's overall performance testing rather than a separate, isolated algorithm-only study as might be conducted for an image analysis AI.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was adherence to established international standards (IEC 60601-1 for electrical safety and physical characteristics, IEC 60601-1-2 for EMC) and the device's own internal design specifications and requirements. For the functional tests, the "ground truth" was whether the device performed its intended function as designed (e.g., connected, powered on, saved files).

8. The Sample Size for the Training Set

The document does not provide information about a "training set" sample size. The device uses "pattern recognition technology to non-invasively acquire user-specific muscle signals." For such systems, the "training set" typically refers to individual patient-specific muscle signal data used to train the system for that particular user. This is a personalized calibration process, not a large, general training dataset used for machine learning model development in the traditional sense as this is a medical device, not a diagnostic AI.

9. How the Ground Truth for the Training Set Was Established

As noted above, for myoelectric pattern recognition systems, the "training" involves a user-specific calibration process. The document states, "Patients can achieve control of their devices, eliminate control switching, and benefit from quick and powerful recalibration." This implies that the "ground truth" for each user's calibration is derived from their own movements and muscle signals, allowing the system to learn the unique patterns associated with their intended prosthetic movements. The system does not rely on a pre-established "ground truth" from a large, independent dataset for its core pattern recognition function, but rather on real-time muscle signal acquisition and mapping by the individual user.

Ask a specific question about this device

The Dome Electrodes are intended for non-invasive use with recording and monitoring equipment of Electromyography (EMG).

The Dome Electrode is an accessory designed for recording of biopotential signals. It is a non-invasive electrode that records biopotential signals from the surface of the skin. It has a standard mating thread that enables connection to electrical conductors of compatible devices. The Dome Electrode contains the following components: 316L Stainless Steel Dome Electrode, Stainless Steel Size 4-40 Nut, Stainless Steel Flat Washer, Stainless Steel Split ("Lock") Washer.

I am sorry, but the provided text does not contain the information required to compose the answer in the requested format. The document is an FDA 510(k) premarket notification for a medical device (Dome Electrode) and primarily focuses on demonstrating substantial equivalence to a predicate device.

Specifically, the text does not contain details about:

• Acceptance Criteria Table with Reported Device Performance: No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are mentioned, nor are quantitative performance results against such criteria for the Dome Electrode itself in terms of signal processing or diagnostic accuracy. The "Result" column in the Non-Clinical Performance Data section only states "Pass" for various internal mechanical and electrical tests.
• Sample Size for Test Set and Data Provenance: While "Signal Detection Test" and "Validation – Compatible Device" are listed, the document does not specify the sample size (number of subjects, number of electrode placements, duration of recording) for these tests, nor the origin of the data (country, retrospective/prospective).
• Number of Experts and Qualifications for Ground Truth: There is no mention of experts establishing ground truth for any test set or their qualifications. The device is a cutaneous electrode for EMG, not an AI diagnostic tool requiring expert consensus for interpretation.
• Adjudication Method: Not applicable as there's no mention of expert review or consensus.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is relevant for AI systems assisting human readers in interpreting images or data. The Dome Electrode is a physical medical device (electrode) and not an AI algorithm. Therefore, no MRMC study was conducted or reported.
• Standalone Performance (Algorithm Only): The device is an electrode, not an algorithm. Standalone performance for an algorithm is not applicable.
• Type of Ground Truth Used: The ground truth for electrode performance would typically be the physical properties of the electrical signals detected. There's no mention of a "ground truth" in the context of expert consensus, pathology, or outcomes data, as would be common for AI/diagnostic devices. The internal tests (voltage continuity, signal detection) likely assess the electrode's ability to pick up and transmit electrical signals, with "Pass" indicating it meets specifications.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: The device is hardware, not a machine learning model. Therefore, there is no "training set" in the context of AI.

The document primarily focuses on:

• Biocompatibility Testing: Conformance to ISO 10993 standards (cytotoxicity, sensitization, irritation) with "passing results."
• Physical and Electrical Performance: Internal tests for mechanical fit, voltage continuity, and signal detection, all reported as "Pass."
• Comparison to a Predicate Device: Detailed comparison of technological characteristics (dimensions, materials, connection type, indications for use, mechanism of action) to establish substantial equivalence.

Given the nature of the device (a cutaneous electrode) and the content of the 510(k) submission, the study design and reporting requirements are very different from those for an AI/ML-based diagnostic device. The document states, "No human clinical testing was required to support the medical device as it was designed to conform to IEEE 2010-2012 Recommended Practice for Neurofeedback Systems. Cutaneous electrodes have been on the market for many years with proven safety and efficacy." This explicitly indicates that complex clinical studies, particularly those involving human interpretation or AI performance metrics, were not part of this submission for this particular device.

Ask a specific question about this device

The COMPLETE CONTROL System is to be used exclusively for external prosthetic fittings of the upper limbs.

The COMPLETE CONTROL System is an advanced control solution designed to enhance the functionality of a powered myoelectric prosthesis for upper extremity amputees. The COMPLETE CONTROL System employs Pattern Recognition technology to acquire, non-invasively, the rich information in muscle signals to enhance the control of industry standard upper extremity prostheses. Patients can achieve intuitive control of their devices, eliminate control switching, and benefit from quick and powerful recalibration. COMPLETE CONTROL simplifies electrode placement and allows a prosthetist to spend less time adjusting system settings and configurations.

The COMPLETE CONTROL System is designed to work seamlessly with most major manufacturers' devices as an easy plug-and-play add-on. COMPLETE CONTROL does not require an additional battery.

The COMPLETE CONTROL System is an embedded system that is used in conjunction with an upper-limb prosthetic device. This device can include any combination of an elbow, wrist, hand or terminal device. It contains several modules, including one for processing surface EMG (CO-AMP), processing and translating the signals (CONTROLLER), along with a controlling training routine (CALIBRATE). Finally, a wireless adapter (COMMUNICATOR) is included with the system setup and is used to provision the entire system.

The COMPLETE CONTROL System contains the following components.

• 1. Device Interface Cable (clinician-specified termination type)
• 2. COMPLETE CONTROLLER main processor
• 3. COMPLETE CALIBRATE patient interface button
• 4. COMPLETE CO-AMP consolidated EMG amplifier
• 5. EMG Interface Cable
• 6. Fabrication aids for the COMPLETE CONTROLLER, COMPLETE CO-AMP, and COMPLETE CALIBRATE
• 7. Socket cut-out template for the COMPLETE CALIBRATE button
• 8. COMPLETE COMMUNICATOR USB dongle
• 9. COMPLETE CONTROLROOM software installation USB dongle

This document, a 510(k) summary for the "COMPLETE CONTROL System" by Coapt, LLC, outlines the device's characteristics and its comparison to a predicate device to establish substantial equivalence for regulatory clearance. It focuses on non-clinical performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, precision, latency) for the device's core function (pattern recognition for myoelectric control). Instead, the "acceptance criteria" are implied to be conformance to various standards and the successful completion of internal validation tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not mention a test set with a specific sample size used for performance evaluation related to the device's primary function of pattern recognition for myoelectric control. The non-clinical performance data described relates to engineering verification and validation testing of the hardware and software components.

The data provenance for these engineering tests would typically be internal laboratory testing conducted by Coapt, LLC or a contracted testing facility. No information about country of origin of data or retrospective/prospective nature is provided for these engineering tests.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable and not provided in the document because the performance evaluation relies on engineering tests and conformance to standards, not on clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document, as there was no test set requiring expert adjudication for clinical or performance outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done and is not mentioned in the document. The device is a "Cutaneous Electrode" (Class II, Product Code GXY) that enhances the control of existing prosthetic devices; it's not a diagnostic imaging device where MRMC studies are typically performed. The document explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done

The document describes "Calibration and Pattern Recognition Test" and "Feature Extraction Test" which would involve the algorithm operating in a standalone manner, processing signals and performing its designated function. However, the exact methodology, metrics, and quantitative results of these algorithm-only tests are not detailed beyond stating they "Passed."

7. The Type of Ground Truth Used

For the engineering tests (e.g., cabling, power, wireless), the ground truth is simply the expected operational output or state of the system (e.g., cable connected correctly, power on, wireless connected). For the "Calibration and Pattern Recognition Test" and "Feature Extraction Test," the ground truth would be the expected or correct pattern recognition output based on the input EMG signals, but the specifics of how this ground truth was defined or evaluated are not elaborated. There is no mention of expert consensus, pathology, or outcomes data as ground truth for these tests.

8. The Sample Size for the Training Set

The document does not mention the sample size for a training set. While the device utilizes "Pattern Recognition technology," the details of its development and training, including the dataset size, are not provided in this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document. Given the use of "Pattern Recognition technology," a training set with associated ground truth (e.g., specific muscle movements or intentions linked to EMG patterns) would typically be required, but the document does not elaborate on this aspect of the device's development.

Ask a specific question about this device